Background—Acute cardiogenic shock (CS) following myocardial infarction (AMI) is associated with high in-hospital mortality due to persisting low cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5 percutaneous left ventricular assist device (pLVAD) in patients with CS following AMI. Methods and Results—This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with CS from AMI receiving temporary circulatory support with the Impella-2.5-pLVAD. The primary endpoint evaluated mortality at 30 days. The secondary endpoint analyzed the change of plasma lactate after institution of hemodynamic support, the rate of early major adverse cardiac and cerebrovascular events (MACCE) as well as long-term survival. 30-day mortality was 64.2% in the study population. After Impella-2.5-pLVAD-implantation, lactate levels decreased from 5.8±5.0mmol/l to 4.7±5.4mmol/l (p= 0.28) and 2.5±2.6mmol/l (p=0.023) at 24 and 48 hours. Early MACCE were reported in 18(15%) patients. Major bleeding at the vascular access site, hemolysis and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%) and 2 (1.7%) patients, respectively. The parameters age>65 and lactate level >3.8mmol/l at admission were identified as predictors of 30day-mortality. After 317±526days of follow-up, survival was 28.3% Conclusions—In patient with acute CS from AMI, Impella 2.5-treatment is feasible and results in a reduction of lactate levels suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.

Percutaneous Left Ventricular Support With the Impella 2.5 Assist Device in Acute Cardiogenic Shock - Results of the Impella EUROSHOCK-Registry. Circulation Heart failure / Alexander, Lauten; Annemarie E., Engström; Christian, Jung; Klaus, Empen; Paul, Erne; Stéphane, Cook; Stephan, Windecke; Martin W., Bergmann; Roland, Klingenberg; Thomas F., Lüscher; Michael, Haude; Dierk, Rulands; Christian, Butter; Bengt, Ullmann; Laila, Hellgren; Modena, Maria Grazia; Giovanni, Pedrazzini; Jose P. S., Henriques; Hans R., Figulla; Markus, Ferrari. - In: CIRCULATION. HEART FAILURE. - ISSN 1941-3289. - STAMPA. - 6:(2013), pp. 23-30. [10.1161/CIRCHEARTFAILURE.112.967224]

Percutaneous Left Ventricular Support With the Impella 2.5 Assist Device in Acute Cardiogenic Shock - Results of the Impella EUROSHOCK-Registry. Circulation Heart failure

MODENA, Maria Grazia;
2013

Abstract

Background—Acute cardiogenic shock (CS) following myocardial infarction (AMI) is associated with high in-hospital mortality due to persisting low cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5 percutaneous left ventricular assist device (pLVAD) in patients with CS following AMI. Methods and Results—This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with CS from AMI receiving temporary circulatory support with the Impella-2.5-pLVAD. The primary endpoint evaluated mortality at 30 days. The secondary endpoint analyzed the change of plasma lactate after institution of hemodynamic support, the rate of early major adverse cardiac and cerebrovascular events (MACCE) as well as long-term survival. 30-day mortality was 64.2% in the study population. After Impella-2.5-pLVAD-implantation, lactate levels decreased from 5.8±5.0mmol/l to 4.7±5.4mmol/l (p= 0.28) and 2.5±2.6mmol/l (p=0.023) at 24 and 48 hours. Early MACCE were reported in 18(15%) patients. Major bleeding at the vascular access site, hemolysis and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%) and 2 (1.7%) patients, respectively. The parameters age>65 and lactate level >3.8mmol/l at admission were identified as predictors of 30day-mortality. After 317±526days of follow-up, survival was 28.3% Conclusions—In patient with acute CS from AMI, Impella 2.5-treatment is feasible and results in a reduction of lactate levels suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.
2013
6
23
30
Percutaneous Left Ventricular Support With the Impella 2.5 Assist Device in Acute Cardiogenic Shock - Results of the Impella EUROSHOCK-Registry. Circulation Heart failure / Alexander, Lauten; Annemarie E., Engström; Christian, Jung; Klaus, Empen; Paul, Erne; Stéphane, Cook; Stephan, Windecke; Martin W., Bergmann; Roland, Klingenberg; Thomas F., Lüscher; Michael, Haude; Dierk, Rulands; Christian, Butter; Bengt, Ullmann; Laila, Hellgren; Modena, Maria Grazia; Giovanni, Pedrazzini; Jose P. S., Henriques; Hans R., Figulla; Markus, Ferrari. - In: CIRCULATION. HEART FAILURE. - ISSN 1941-3289. - STAMPA. - 6:(2013), pp. 23-30. [10.1161/CIRCHEARTFAILURE.112.967224]
Alexander, Lauten; Annemarie E., Engström; Christian, Jung; Klaus, Empen; Paul, Erne; Stéphane, Cook; Stephan, Windecke; Martin W., Bergmann; Roland, Klingenberg; Thomas F., Lüscher; Michael, Haude; Dierk, Rulands; Christian, Butter; Bengt, Ullmann; Laila, Hellgren; Modena, Maria Grazia; Giovanni, Pedrazzini; Jose P. S., Henriques; Hans R., Figulla; Markus, Ferrari
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